The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Lg Light Chains, Type Kappa, Dimension Vista Lg Light Chains, Type Lambda, Dimension Vista Protein 1 Cal.
| Device ID | K082503 |
| 510k Number | K082503 |
| Device Name: | DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Anna Marie Kathleen Ennis |
| Correspondent | Anna Marie Kathleen Ennis SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-29 |
| Decision Date | 2008-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768024436 | K082503 | 000 |
| 00842768024429 | K082503 | 000 |
| 00842768006357 | K082503 | 000 |